The aim of the study is to assess whether the second CYD dengue vaccination could be administered concomitantly with the booster vaccination of a pediatric combination vaccine (Pentaxim™) during the same day and visit but in 2 different sites of administration.

Primary Objective:

To demonstrate the non-inferiority of the antibody response against all antigens (diphtheria, tetanus, pertussis, polio and Hib) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to subjects receiving one booster dose of Pentaxim™ vaccine administered concomitantly with placebo.

Secondary Objectives:

To describe the safety of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine, or administered concomitantly with placebo.

To describe the safety of the CYD dengue vaccine in all subjects after each dose.

To describe the antibody response to each dengue virus serotype (post-Dose 2 and post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine or administered alone.

To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3 in all subjects.

Neutralizing antibody levels against each of the 4 dengue virus serotype strains contained in the CYD dengue vaccine will be measured in sera collected from a randomized subset of participants using the dengue plaque reduction neutralization test (PRNT).

Participants will require 8 or 9 clinic visits and will receive a total of 7 injections. The dengue post-vaccinal viremia will be assessed at Visit 2 from a subset of toddlers. The dengue immunogenicity will be assessed 28 days after CYD dengue dose 2 and dose 3 from a subset of toddlers. All participants will be followed-up for safety after each vaccine dose and for 6 months after the last dengue vaccination.

Eligibility

Ages Eligible for Study:

9 Months to 12 Months

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Aged 9 to 12 months on the day of inclusion.

Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.

Subject in good health, based on medical history and physical examination.

Documentation of completion of the primary vaccination series with Pentaxim vaccine with the 2-4-6 month regimen ± 2 weeks for each vaccination.

Informed consent form has been signed and dated by both parents or other legally acceptable representative (and by 2 mandatory witnesses as required by local regulations).

Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.

Planned participation in another clinical trial during the present trial period.

Planned receipt of any vaccine in the 4 weeks following any trial vaccination.

Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response.

Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01411241